Benedikt Schrage1, Karim Ibrahim2, Tobias Loehn2, Nikos Werner3, Jan-Malte Sinning3, Federico Pappalardo4, Marina Pieri4, Carsten Skurk5, Alexander Lauten5, Ulf Landmesser5, Ralf Westenfeld6, Patrick Horn6, Matthias Pauschinger7, Dennis Eckner7, Raphael Twerenbold1,8, Peter Nordbeck9, Tim Salinger9, Peter Abel10,11, Klaus Empen10,11, Mathias C Busch10,11, Stephan B Felix10,11, Jan-Thorben Sieweke12, Jacob Eifer Møller13, Nilesh Pareek14, Jonathan Hill14, Philip MacCarthy14, Martin W Bergmann15, José P S Henriques16, Sven Möbius-Winkler17, P Christian Schulze17, Taoufik Ouarrak18, Uwe Zeymer18,19, Steffen Schneider18, Stefan Blankenberg1,20, Holger Thiele21, Andreas Schäfer12, Dirk Westermann1,20. 1. University Heart Centre Hamburg, Department of General and Interventional Cardiology, Germany (B.S., R.T., S.B., D.W.). 2. University Heart Centre Dresden, Department of Cardiology and Intensive Care, Germany (K.I., T.L.). 3. University Heart Centre Bonn, Department of Cardiology, Germany (N.W., J-M.S.). 4. San Raffaele Scientific Institute Milan, Anaesthesia and Intensive Care Department, Italy (F.P., M.P.). 5. Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Department of Cardiology, Germany (C.S., A.L., U.L.). 6. Heinrich Heine University Düsseldorf, Department of Cardiology, Pulmonology and Vascular Medicine, Germany (R.W., P.H.). 7. Paracelsus Medical University Nürnberg, Department of Cardiology, Germany (M.P., D.E.). 8. Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland (R.T.). 9. University Hospital Würzburg, Department of Internal Medicine I, Germany (P.N., T.S.). 10. German Centre for Cardiovascular Research, Partner Site Greifswald (P.A., K.E., M.C.B., S.B.F.). 11. University Medicine Greifswald, Department of Internal Medicine B, Division of Cardiology, Germany (P.A., K.E., M.C.B., S.B.F.). 12. Hannover Medical School, Department of Cardiology and Angiology, Germany (J.T.S., A.S.). 13. University Hospital Odense, Department of Cardiology, Denmark (J.E.M.). 14. King's College Hospital National Health Service Foundation Trust, London, United Kingdom (N.P., J.H., P.M.). 15. Cardiologicum Hamburg, Germany (M.W.B.). 16. Academic Medical Centre Heart Centre, Academic Medical Centre-University of Amsterdam, the Netherlands (J.P.S.H.). 17. University Hospital Jena, Department of Internal Medicine I, Germany (S.M-W., P.C.S.). 18. Stiftung Institut für Herzinfarktforschung, Ludwigshafen, Germany (T.O., U.Z., S.S.). 19. Klinikum der Stadt Ludwigshafen, Department of Cardiology, Ludwigshafen am Rhein, Germany (U.Z.). 20. German Centre for Cardiovascular Research, Partner Site Hamburg/Kiel/Lübeck, Hamburg, Germany (S.B., D.W.). 21. Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology, Germany (H.T.).
Abstract
BACKGROUND: Percutaneous mechanical circulatory support devices are increasingly used in acute myocardial infarction complicated by cardiogenic shock (AMI-CS), despite limited evidence for their effectiveness. The aim of this study was to evaluate outcomes associated with use of the Impella device compared with intra-aortic balloon pump (IABP) and medical treatment in patients with AMI-CS. METHODS: Data of patients with AMI-CS treated with the Impella device at European tertiary care hospitals were collected retrospectively. All patients underwent early revascularization and received optimal medical treatment. Using IABP-SHOCK II (Intraaortic Balloon Pump in Cardiogenic Shock II) trial inclusion and exclusion criteria, 372 patients were identified and included in this analysis. These patients were matched to 600 patients from the IABP-SHOCK II trial. The following baseline criteria were used as matching parameters: age, sex, mechanical ventilation, ejection fraction, prior cardiopulmonary resuscitation, and lactate. Primary end point was 30-day all-cause mortality. RESULTS: In total, 237 patients treated with an Impella could be matched to 237 patients from the IABP-SHOCK II trial. Baseline parameters were similarly distributed after matching. There was no significant difference in 30-day all-cause mortality (48.5% versus 46.4%, P=0.64). Severe or life-threatening bleeding (8.5% versus 3.0%, P<0.01) and peripheral vascular complications (9.8% versus 3.8%, P=0.01) occurred significantly more often in the Impella group. Limiting the analysis to IABP-treated patients as a control group did not change the results. CONCLUSIONS: In this retrospective analysis of patients with AMI-CS, the use of an Impella device was not associated with lower 30-day mortality compared with matched patients from the IABP-SHOCK II trial treated with an IABP or medical therapy. To further evaluate this, a large randomized trial is warranted to determine the effect of the Impella device on outcome in patients with AMI-CS. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03313687.
BACKGROUND: Percutaneous mechanical circulatory support devices are increasingly used in acute myocardial infarction complicated by cardiogenic shock (AMI-CS), despite limited evidence for their effectiveness. The aim of this study was to evaluate outcomes associated with use of the Impella device compared with intra-aortic balloon pump (IABP) and medical treatment in patients with AMI-CS. METHODS: Data of patients with AMI-CS treated with the Impella device at European tertiary care hospitals were collected retrospectively. All patients underwent early revascularization and received optimal medical treatment. Using IABP-SHOCK II (Intraaortic Balloon Pump in Cardiogenic Shock II) trial inclusion and exclusion criteria, 372 patients were identified and included in this analysis. These patients were matched to 600 patients from the IABP-SHOCK II trial. The following baseline criteria were used as matching parameters: age, sex, mechanical ventilation, ejection fraction, prior cardiopulmonary resuscitation, and lactate. Primary end point was 30-day all-cause mortality. RESULTS: In total, 237 patients treated with an Impella could be matched to 237 patients from the IABP-SHOCK II trial. Baseline parameters were similarly distributed after matching. There was no significant difference in 30-day all-cause mortality (48.5% versus 46.4%, P=0.64). Severe or life-threatening bleeding (8.5% versus 3.0%, P<0.01) and peripheral vascular complications (9.8% versus 3.8%, P=0.01) occurred significantly more often in the Impella group. Limiting the analysis to IABP-treated patients as a control group did not change the results. CONCLUSIONS: In this retrospective analysis of patients with AMI-CS, the use of an Impella device was not associated with lower 30-day mortality compared with matched patients from the IABP-SHOCK II trial treated with an IABP or medical therapy. To further evaluate this, a large randomized trial is warranted to determine the effect of the Impella device on outcome in patients with AMI-CS. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03313687.
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